Novoeight

"The U.S. Food and Drug Administration today approved Tretten, Coagulation Factor XIII A-Subunit (Recombinant), the first recombinant product for use in the routine prevention of bleeding in adults and children who have a rare clotting disorder, k"...

Novoeight

PATIENT INFORMATION

Read the Patient Product Information and the
Instructions For Use that come with Novoeight before you start taking this
medicine and each time you get a refill. There may be new information.

This Patient Product Information does not take the place
of talking with your healthcare provider about your medical condition or
treatment. If you have questions about Novoeight after reading this
information, ask your healthcare provider.

What is the most important information I need to know
about Novoeight?

Do not attempt to do an infusion yourself unless you
have been taught how by your healthcare provider or hemophilia center.

You must carefully follow your healthcare provider's
instructions regarding the dose and schedule for infusing Novoeight so that your
treatment will work best for you.

What is Novoeight?

Novoeight is an injectable medicine used to replace
clotting factor VIII that is missing in patients with hemophilia A. Hemophilia
A is an inherited bleeding disorder that prevents blood from clotting normally.

Novoeight is used to control and prevent bleeding in
people with hemophilia A.

Your healthcare provider may give you Novoeight when you
have surgery.

are allergic to factor VIII or any of the other
ingredients of Novoeight

if you are allergic to hamster proteins

Tell your healthcare provider if you are pregnant or
nursing because Novoeight might not be right for you.

What should I tell my healthcare provider before I use
Novoeight?

You should tell your healthcare provider if you

Have or have had any medical conditions.

Take any medicines, including non-prescription medicines
and dietary supplements.

Are nursing.

Are pregnant or planning to become pregnant.

Have been told that you have inhibitors to factor VIII.

How should I use Novoeight?

Treatment with Novoeight should be started by a
healthcare provider who is experienced in the care of patients with hemophilia
A.

Novoeight is given as an injection into the vein.

You may infuse Novoeight at a hemophilia treatment
center, at your healthcare provider's office or in your home. You should be
trained on how to do infusions by your hemophilia treatment center or
healthcare provider. Many people with hemophilia A learn to infuse the medicine
by themselves or with the help of a family member.

Your healthcare provider will tell you how much Novoeight
to use based on your weight, the severity of your hemophilia A, and where you
are bleeding.

You may need to have blood tests done after getting
Novoeight to be sure that your blood level of factor VIII is high enough to
clot your blood. This is particularly important if you are having major
surgery.

Call your healthcare provider right away if your
bleeding does not stop after taking Novoeight.

Development of factor VIII inhibitors

Your body can also make antibodies called “inhibitors”
against Novoeight, which may stop Novoeight from working properly.

If your bleeding is not adequately controlled, it could
be due to the development of factor VIII inhibitors. This should be checked by
your healthcare provider. You might need a higher dose of Novoeight or even a
different product to control bleeding. Do not increase the total dose of
Novoeight to control your bleeding without consulting your healthcare provider.

Use in children

Novoeight can be used in children. Your healthcare
provider will decide the dose of Novoeight you will receive.

If you forget to use Novoeight

Do not inject a double dose to make up for a forgotten
dose. Proceed with the next injections as scheduled and continue as advised by
your healthcare provider.

If you stop using Novoeight

If you stop using Novoeight you are not protected against
bleeding. Do not stop using Novoeight without consulting your healthcare
provider.

If you have any further questions on the use of this
product, ask your healthcare provider.

What if I take too much Novoeight?

Always take Novoeight exactly as your healthcare provider
has told you. You should check with your healthcare provider if you are not
sure. If you inject more Novoeight than recommended, tell your healthcare
provider as soon as possible.

What are the possible side effects of Novoeight?

Common Side Effects Include:

swelling or itching at the location of injection

changes in liver tests

fever

Other Possible Side Effects:

You could have an allergic reaction to coagulation factor
VIII products. Call your healthcare provider right away and stop treatment
if you get any of the following signs of an allergic reaction:

These are not all of the possible side effects from
Novoeight. Ask your healthcare provider for more information. You are
encouraged to report side effects to FDA at 1-800-FDA-1088.

Tell your healthcare provider about any side effect that
bothers you or that does not go away.

What are the Novoeight dosage strengths?

Novoeight comes in six different dosage strengths. The
actual number of international units (IU) of factor VIII in the vial will be
imprinted on the label and on the box. The six different strengths are as
follows:

Dosage strength of approximately 250 IU per vial

Dosage strength of approximately 500 IU per vial

Dosage strength of approximately 1000 IU per vial

Dosage strength of approximately 1500 IU per vial

Dosage strength of approximately 2000 IU per vial

Dosage strength of approximately 3000 IU per vial

Always check the actual dosage strength printed on the
label to make sure you are using the strength prescribed by your doctor.

How should I store Novoeight?

Prior to Reconstitution:

Store in original package in order to protect from light.
Do not freeze Novoeight.

Novoeight vials can be stored in the refrigerator
(36-46°F [2°C – 8°C]) for up to 2 years or up to the expiration date, or at
room temperature (up to 86°F [30°C]) for a single period not exceeding 6
months.

If you choose to store Novoeight at room temperature:

Note the date that the product is removed from
refrigeration on the box.

Do not use after 6 months from this date or the
expiration date listed on the vial, whichever is earlier.

Do not return the product to the refrigerator.

If the product is moved in and out of the refrigerator, a
log must be kept to ensure that the total time does not exceed 6 months.

Do not use this medicine after the expiration date which
is on the outer carton, the vial and the pre-filled syringe. The expiration
date refers to the last day of that month.

After Reconstitution (mixing the dry powder in the
vial with the diluent):

The reconstituted Novoeight should appear clear to
slightly unclear without particles.

The reconstituted Novoeight should be used immediately.

If you cannot use the Novoeight immediately after it is
mixed, it should be used within 4 hours when stored at ≤ 86°F (30°C).
Store the reconstituted product in the vial.

Keep this medicine out of the sight and out of reach of
children.

What else should I know about Novoeight and hemophilia
A?

Medicines are sometimes prescribed for purposes other
than those listed here. Do not use Novoeight for a condition for which it is
not prescribed. Do not share Novoeight with other people, even if they have the
same symptoms that you have.

For more information about Novoeight, please call Novo
Nordisk at 1-877-NOVO-777.

Novoeight® is supplied as a powder. Before injection
(administration) it must be mixed (reconstituted) with the liquid diluent
supplied in the syringe. The liquid diluent is a sodium chloride buffer. The
mixed Novoeight® must be injected into your vein (intravenous injection). The
equipment in this package is designed to mix and inject Novoeight®.

You will also need an infusion set (tubing and butterfly
needle), sterile alcohol swabs, gauze pads, and bandages.

Don't use the equipment without proper training from
your doctor or nurse.

Always wash your hands and ensure that the area around
you is clean.

When you prepare and inject medication directly into the
veins, it is important to use a clean and germ free (aseptic) technique.
Improper technique can introduce germs that can infect the blood.

Don't open the equipment until you are ready to use
it.

Don't use the equipment if it has been dropped, or if
it is damaged. Use a new package instead.

Don't use the equipment if it is expired. Use a
new package instead. The expiration date is printed on the outer carton and on
the vial, the vial adapter and the pre-filled syringe.

Don't use the equipment if you suspect it is
contaminated. Use a new package instead.

Don't dispose of any of the items until after you have
injected the mixed solution.

The equipment is for single use only.

Content

The package contains:

Vial with Novoeight® powder

Vial adapter

Pre-filled syringe with diluent

Plunger rod (placed under the syringe)

Overview

1. Prepare the vial and the
syringe

Take out the number of
Novoeight® packages you need.

Check the expiry date.

Check the name and the color
of the package, to make sure it contains the correct product.

Wash your hands and dry them properly
using a clean towel or air dry.

Take the vial, the vial adapter
and the pre-filled syringe out of the carton. Leave the plunger rod
untouched in the carton.

Bring the vial and the
pre-filled syringe to room temperature. You can do this by holding them in your hands until they
feel as warm as your hands.

Remove the plastic cap from the vial. If the plastic cap is loose or missing,
don't use the vial.

Wipe the rubber stopper with
a sterile alcohol swab and allow it to air dry for a few seconds before use to
ensure that it is as germ free as possible.

Don't touch the rubber
stopper with your fingers as this can
transfer germs.

2. Attach the vial adapter

Remove the protective paper from the vial adapter.

Don't take the vial adapter
out of the protective cap with your fingers.
If you touch the spike on the vial adapter
germs from your fingers can be transferred.

If the protective paper is
not fully sealed or if it is broken, don't use the vial adapter.

Place the vial on a flat and
solid surface.

Turn over the protective
cap, and
snap the vial adapter onto the vial.

Once attached, don't remove
the vial adapter from the vial.

Lightly squeeze the
protective cap with your thumb and index finger as shown. Remove the
protective cap from the vial adapter.

Don't lift the vial adapter
from the vial when removing the protective cap.

3. Attach the plunger rod
and the syringe

Grasp the plunger rod by the
wide top end and take it out of the carton. Don't touch the sides or the
thread of the plunger rod. If you touch the sides or the thread germs from
your fingers can be transferred.

Immediately connect the plunger rod
to the syringe by turning it clockwise into the rubber plunger inside the
pre-filled syringe until resistance is felt.

Remove the syringe cap from the pre-filled
syringe by bending it down until the perforation breaks.

Don't touch the syringe tip
under the syringe cap. If you touch the syringe tip germs from your fingers can be
transferred.

If the syringe cap is loose
or missing, don't use the pre-filled syringe.

Screw the pre-filled syringe
securely onto the vial adapter until
resistance is felt.

Use a clean and germ free (aseptic) technique. Ask your
doctor or nurse for specific instructions.

If the line needs to be flushed before or after Novoeight®
injection, use 0.9% Sodium Chloride Injection, USP.

Disposal

After injection, safely
dispose of
all unused Novoeight® solution, the syringe with the infusion set, the vial
with the vial adapter, and other waste materials in an appropriate container
for throwing away medical waste.

Don't throw it out with the
ordinary household trash.

Don't disassemble the vial
and vial adapter before disposal.

Don't reuse the equipment.

Important information

Contact your healthcare
provider or local hemophilia treatment center if you experience any problems.

For full Prescribing
Information please read the other insert included in this package.

Last reviewed on RxList: 3/25/2014
This monograph has been modified to include the generic and brand name in many instances.